Biopsy device with selectable tissue receiving aperature orientation and site illumination

ABSTRACT

A method for collecting a tissue specimen from a target site within a patient includes rotating an elongated tubular section about a longitudinal axis to provide a desired aperture orientation of a tissue receiving aperture; applying a vacuum within the elongated tubular section to draw tissue at the tissue site through the tissue receiving aperture of the elongated tubular section into the interior thereof; advancing an elongated tissue cutting member longitudinally within the elongated tubular section to cut a tissue specimen from the tissue extending into the elongated tubular section; and applying a vacuum to the proximal end of the elongated tissue cutting member for transporting a cut tissue specimen through the inner lumen of the elongated tissue cutting member to discharge the cut tissue specimen directly from the proximal end of the elongated tissue cutting member into a tissue collection device.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 12/229,545,filed Aug. 25, 2008, now U.S. Pat. No. 9,044,215, which is a divisionalof application Ser. No. 10/911,106, filed Aug. 3, 2004, now U.S. Pat.No. 8,282,573, which is a continuation-in-part of application Ser. No.10/642,406, filed Aug. 15, 2003, now U.S. Pat. No. 7,819,819, which is acontinuation-in-part of application Ser. No. 10/374,915, filed on Feb.24, 2003, now U.S. Pat. No. 7,189,206, all of which are incorporatedherein by reference in their entirety and from which priority isclaimed. This application is also related to application Ser. No.12/229,553, filed Aug. 25, 2008, which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to tissue removing devices suchas biopsy devices and the methods of using such devices. Morespecifically, it is directed to a device and method for accessing andremoving pathologically suspect tissue from within a patient's body.

BACKGROUND OF THE INVENTION

In diagnosing and treating certain medical conditions, such aspotentially cancerous tumors, it is usually desirable to perform abiopsy, in which a specimen of the suspicious tissue is removed forpathological examination and analysis. In many instances, the suspicioustissue is located in a subcutaneous site, such as inside a human breast.To minimize surgical intrusion into the patient's body, it is desirableto be able to insert a small instrument into the patient's body toaccess the targeted site and to extract the biopsy specimen therefrom.

Electrosurgical techniques have been used in a variety of biopsyprocedures. In electrosurgery, high frequency electrical energy istypically applied to patient tissue through an active electrode, theelectrical circuit being completed by a return electrode in contact withthe patient's tissue. Electrical energy flowing through the tissue fromthe active electrode is effective to ablate tissue near the activeelectrode, forming an opening in the tissue and so allowing insertion ofthe instrument into a patient's body. A return electrode may be placedon the exterior of the patient's body or may be incorporated into thedevice itself. The return electrode is typically attached to the patientat a point remote from where the primary or active electrode contactsthe tissue. However, in the case of a bipolar electrode for example, thereturn electrode may be disposed near to the active electrode. Anelectrosurgical biopsy instrument is disclosed and claimed in U.S.patent application Ser. No. 09/159,467 for “Electrosurgical BiopsyDevice and Method,” now U.S. Pat. No. 6,261,241, assigned to theassignee of the present application, and which is hereby incorporated byreference in its entirety.

While these electrosurgical biopsy devices have been found to beeffective in many instances, they may not always be suitable for use inconjunction with magnetic resonance imaging.

SUMMARY OF THE INVENTION

This invention is directed to devices for accessing and severing tissuefrom a target site within a patient and methods for utilizing suchdevices. The devices embodying features of the invention provide accessto a targeted tissue site within a patient and provide for theselection, separation and capture of a tissue specimen from supportingtissue at the targeted site.

A tissue collection device and system having features of the inventiongenerally include an elongated, preferably disposable probe componenthaving a plurality of operative elements and a driver componentconfigured to receive the elongated probe component and drive thevarious operative elements of the probe component.

The elongated probe component has a distal shaft portion with a tissuepenetrating distal tip, a tubular section proximal to the distal tip, aninner lumen extending within the tubular section and an open, tissuereceiving aperture in the tubular section which provides access totissue at the targeted site. The probe component includes an elongatedtissue-cutting member, which is preferably at least in partcylindrically shaped. The tissue cutting member is provided with atleast one tissue cutting edge which is configured to sever tissueextending into the interior of the tubular section through the aperturethereof. The cutting edge on the tissue cutting member may be configuredfor longitudinal cutting movement and may include oscillating rotationalmotion and/or reciprocating longitudinal motion to sever specimen tissueextending through the aperture from supporting tissue at the targetedsite. The cutting surfaces or edges are radially spaced from alongitudinal axis of the probe component and are generally transverselyoriented with respect to the longitudinal axis. The tissue cutter ispreferably slidably disposed within the inner lumen of the tubularsection, although it may be disposed about the tubular section. Theprobe component may also have a handle which releasably engages thedriver component.

In one embodiment of the invention, the cutting member has an innerlumen preferably extending to the proximal end thereof for tissuespecimen removal. While mechanical withdrawal of the tissue specimen maybe employed, it is preferred to provide a vacuum within the cuttingmember from the proximal end of the cutting member. The proximal end ofthe cutting member may be configured to be in fluid communication with avacuum source to aspirate the severed tissue specimen through the innerlumen of the cutting member to a tissue collection station. A higherfluid pressure may be maintained in the inner lumen of the cuttingmember distal to the tissue specimen to aid in transporting the specimenproximally through the inner lumen. In this manner, the mechanicalwithdrawal and/or the vacuum on the proximal end of the specimen and ahigher pressure on the distal end of the specimen can move the specimenthrough the inner lumen of the cutting member to a tissue collectionstation.

In at least one embodiment, the handle of the probe component issecured, preferably releasably secured, to the driver housing providedto operably connect the various operative elements of the probe withoperative elements of the driver component. The tissue cutting member isoperatively connected to at least one driver to provide the desiredcutting motion. The proximal end of the tubular section is rotatablysecured within the handle housing so that the orientation thereof withrespect to the longitudinal axis and therefore the orientation of thetissue receiving aperture within the tubular section, can be selected.The orientation of the aperture may be selected manually such asdescribed in copending application Ser. No. 10/642,406, filed FebruaryAugust 15, 2003 or it may be preset or selected electronically by acontrol module which also controls the operation of the cutting memberand electrical power. The aperture orientation setting may be selectedbefore or after the distal portion of the probe component is insertedinto the patient.

The driver component has at least two and preferably three driver unitsfor operating the probe component secured to the driver component.Specifically, the driver component has a first driver unit for rotatingthe tubular section of the probe component, a second driver unit formoving the cutting member along a longitudinal axis of the cuttingmember and optionally a third driving unit for rotating or oscillatingthe cutting member about the longitudinal axis. The first driver unitrotates the tubular section of the probe component, preferably indiscrete steps, so that the location of the tissue receiving aperture inthe distal extremity of the tubular section can be selected prior to orduring the procedure. The discrete rotational steps of the tubularsection are preferably in 30° or multiples thereof so that therotational movement will follow 12 hour clock markings. Preferably, thesecond and third driver units are operable together so that the cuttingmember may rotate or oscillate about a longitudinal axis as the cuttermember is moved longitudinally. This allows a rotation or an oscillationof the cutter during the cutting process which can aid in cuttingtissue.

The driver component may have one or more light sources in a distalportion thereof to illuminate the accessing site during the procedure.

A method of cutting and collecting a tissue specimen with a tissuecollection device embodying features of the invention includes advancingsuch a device at least partially into tissue at a desired site withinthe patient's body with the tissue penetrating distal tip of the outercannula disposed distal to the tissue specimen to be separated from thetarget site. A vacuum is established within the inner lumen of thetubular section to draw tissue through the aperture therein into theinner lumen of the tubular section. The cutting member, which isslidable disposed within the inner lumen of the tubular section, maythen be moved longitudinally to cut a tissue specimen from supportingtissue at the target site by the longitudinal motion, which preferablyincludes oscillating rotational movement and/or reciprocatinglongitudinal movement. The vacuum established within the inner lumen ofthe tubular section may be applied through the inner lumen of the tissuecutting member when the tissue cutting member is disposed within thetubular section. The applied vacuum within the inner lumen of the tissuecutting member, may also be utilized to pull or aspirate the separatedtissue sample proximally. In addition, or alternatively, a higher fluidpressure may be maintained in a distal part of the inner lumen of thetubular section, distal to the specimen, to push the tissue specimenproximally, Alternatively, the tissue specimen may be mechanicallywithdrawn. Fluid pressure may include pressure from a liquid deliveredinto the interior of the device, such as a physiological salinesolution, and may include a gas, such as pressurized carbon dioxide,nitrogen or air, delivered into the interior of the device. Access toambient air can also maintain a sufficiently high pressure differentialto move the specimen through the inner lumen of the cutting member.Anesthetic may be injected to the target site through the outer cannulaor the inner lumen of the cutting member. Upon removal from the patient,the tissue specimen may then be subjected to pathological examination.After acquisition of a tissue specimen or specimens, the tissueseparation system may be repositioned for further tissue separation andcollection or it may be withdrawn from the patient.

The tubular section of the probe provides the support for the probe toenable precise location of the accessing port to the desired location atthe target site with its radial orientations being preset before thedevice is introduced into the patient or selected after the tubularsection is disposed within the patient. The cutting member quickly andcleanly severs the tissue specimen drawn into the interior of thetubular section though the aperture by the action of the vacuum orotherwise. Upon removal of the tissue specimen, the tissue receivingaperture may be radially repositioned about the longitudinal axis of thetubular section of the probe component so that a plurality of specimensmay be taken from the target site. The orientation of the tissuereceiving aperture during the procedure may follow a preselected patternor may be selected by the physician for other selected tissue specimens.

A tissue acquisition system assembly embodying features of the inventionmay include a device for delivery of one or more marker bodies through atubular member of a biopsy device such as the tubular cutting member.Such a marker delivery device includes an elongated shaft having aninner lumen and a discharge opening in a distal portion of the elongatedshaft, at least one marker body which is disposed within the inner lumenof the elongated shaft, a pusher element which is slidably disposedwithin the delivery device and which is configured to urge at least onemarker body out the discharge opening in the distal portion of theelongated shaft. The marker delivery device has a distally flared guidemember which is slidably disposed on the elongated shaft to guide thedistal portion of the elongated shaft into a proximal end of the tubularmember of a biopsy device.

These and other advantages of the invention will become more apparentfrom the following detailed description of the invention and theaccompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of the elongated tissue biopsy systemembodying features of the invention.

FIG. 2 is a perspective view of the embodiment shown in FIG. 1 in anassembled condition without a housing cover for the probe component.

FIG. 3 is a side elevational view of the tissue biopsy device shown inthe FIG. 2.

FIG. 4A is a longitudinal cross-section of the probe shown in FIG. 3taken along the lines 4-4 with the tissue cutting element in a withdrawnposition.

FIG. 4B is a longitudinal cross-section of the probe shown in FIG. 3taken along the lines 4-4 with the tissue cutting element in a forwardor closed position.

FIG. 5 is a transverse cross-sectional view of the probe shown in FIG.4B taken along the lines 5-5.

FIG. 6 is a perspective view of the underside of the probe shown in FIG.1.

FIG. 7 is an enlarged perspective view of the distal end of the driverunit shown in FIG. 1.

FIG. 8 is an enlarged perspective view of the distal end of the probehousing illustrating a marker element which depicts the orientation ofthe aperture in the tubular section of the biopsy device.

FIG. 9 is a perspective view of the tissue biopsy system shown in FIG. 1assembled and mounted on a stereotactic frame.

FIG. 10 is a perspective view of the underside of the driver shown inFIG. 1.

FIG. 11 is an elevational view of a marker delivery device with a flaredguide on the distal end of the shaft which facilitates guiding thedistal tip of a marker delivery device into the interior of the proximalend of the tissue cutter.

FIG. 12 is a longitudinal cross-sectional view of the distal end of themarker delivery device and flared guide disposed within the tissuecollection component shown in FIG. 1.

FIG. 13 is a longitudinal cross sectional view of the proximal end ofthe marker delivery device with the flared guide at the proximal end ofthe shaft and with the shaft deployed within the inner lumen of thetissue cutter.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

FIGS. 1-3 illustrate a biopsy system 10 embodying features of theinvention which includes a disposable probe component 11, a drivercomponent 12 and specimen collector 13.

The probe component 11 generally includes an elongated distal shaft 14having a tubular section or cannula 15 with a tissue penetrating tip 16on the distal end thereof and an open, tissue receiving aperture 17. Theprobe component 11 also includes a probe housing 18 with a housing cover19 which is configured to interfit with the driver component 12. Atissue cutter 20 is slidably disposed within the probe and has a distalcutting surface 21 which severs tissue which extends through the tissuereceiving aperture 17.

Details of the probe component 11 are further shown in FIGS. 4A and 4B.The probe housing 18 has a mechanical system for rotating the housingand the tubular section 15 secured thereto to control the angularposition of the tissue receiving aperture 17 and for moving the tissuecutter 20 slidably disposed within the probe component 11.

The mechanical system of the driver component 12 has first driving gear22 that is configured to engage the probe gear 23 and rotate the probehousing 18 so as to adjust the orientation of aperture 17 in the distalextremity of the tubular section 15. The probe gear 23 is secured to therotating connector body 24 by adhesive 25. The proximal extremity of thetubular section 15 is secured to the rotating connector body 24 byadhesive 26. An end cap 27 retains the connector body 24 within theprobe housing 18. Rotation of the probe gear 23 rotates the connectorbody 24 and the attached tubular section 15. The rotation is preferablycontrolled so that the tubular section 15 rotates in discrete stepsabout the longitudinal axis 28 to adjust the angular orientation of theaperture 17 about the longitudinal axis. Preferably these discreteorientations may be provided in increments of 30° which can be readilyindicated by arrow 29 at the distal end of the probe housing 18 as shownin FIG. 8.

The second driving gear 30 is configured to drive the tissue cutter 20longitudinally. The driving gear 30 engages probe gear 31 which drivescutter traverse nut 32 and cutter screw 33 threadably connected to thecutter traverse nut. The distal end of the cutter screw 33 is providedwith a recess 34 which receives the rib 35 of the cutter shuttle 36. Thecutter shuttle 36 is secured to the tissue cutter 20 by adhesive 37. Theprobe gear 31 is secured to the cutter traverse nut 32 by adhesive 38.Rotation of the probe gear 31 adjusts the relative axial position of thecutter screw 33 with respect to the cutter traverse nut 32 which issecured to the cutter shuttle 36. Longitudinal movement of the tissuecutter 20 follows the longitudinal movement of the cutter shuttle 36resulting from the movement of cutter screw 33. The length of the tissuereceiving aperture 17, and as a result the length of the specimen, canbe controlled by adjusting the initial longitudinal position of thedistal end of the tissue cutter 20 within the aperture, before cutting.

The third driving gear 40 is configured to rotate or oscillate thetissue cutter 20 as the cutter moves along the longitudinal axis 28 tofacilitate the cutting action of the cutting surface 21 on the distalend of the cutter. The third driving gear 40 engages probe gear 41 whichis secured to cutter oscillation shaft 42 by adhesive 43. The probe gear41 may be oscillated back and forth about the longitudinal axis 28 orrotated continuously in a single direction about the longitudinal axis,or both depending upon the desired rotational movement of the tissuecutter.

A biased valve assembly 44 is provided in the distal end of the probehousing 18 to ensure sealing when a vacuum is developed within theinterior 45 of the tissue cutter 20 while providing an atmospheric vent46 between the interior surface 47 of the tubular section 15 and theexterior surface 48 of the tissue cutter 20. The valve assembly 44includes a spring 49, valve body 50 and a valve collar 51 which issecured to the proximal end of the tubular section 15 by adhesive 52.The proximal end of the valve spring 49 rests against the shoulder 53provided in the exterior of the valve body 50. A biased cutter shaftseal 54 slidably engages the exterior 48 of the tissue cutter 20.

The tissue specimen collector 13 is secured to the proximal end of thehousing of probe component 11 and has an interior 55 in fluidcommunication with the inner lumen 56 extending within the tissue cutter20 and has a removable proximal wall 57 of specimen receiving cartridge58 which gives access to the interior 55 and any tissue specimens whichmay have been drawn therein. A vacuum is generated within the interior55 to draw tissue specimens through the inner lumen 45 into the interior55. Tubular member 59 has a distal end which is in fluid communicationwith the interior 55 of the tissue specimen collector 13 and has aproximal end (not shown) which is configured to be connected to a vacuumsource. Application of a vacuum within the tubular member 59 aids inpulling tissue into the interior 17 of the tubular section 15 andtransfer of the severed tissue specimen through the inner lumen 45 ofthe tissue cutter 20 to the specimen cartridge 58.

The driver 12 has a housing 60 with an upper concave surface 61 which isconfigured to receive the lower surface 62 of the probe housing 18.Three partially exposed driving gears 22, 30 and 40 are provided on theproximal end of the driver 12 which are configured to engage the probegears 23, 31 and 41 respectively. The drive 12 is provided with threeseparately operating drive motors (not shown) which drive the drivegears 22, 30 and 40. The separate drive motors (not shown) are connectedto and the operation thereof controlled by a control module, such asdescribed in copending application Ser. No. 10/847,699, filed on May 17,2004. The control module controls the motors which move the individualdrive gears 22, 30 and 40. The gear 22 engages gear 23 in the probe 11to control the rotation of the probe housing 18 and the location andorientation of the tissue receiving aperture 17. The drive gear 30engages probe gear 31 to control the longitudinal position and motion ofthe tissue cutter 20 along the longitudinal axis 28. Drive gear 40engages probe gear 41 to control the oscillation or rotation of thetissue cutter 20 about the longitudinal axis 28.

As shown in FIG. 7, the front face of the driver component 12 isprovided with light sources 66 and 67 and a manually activatable switch68 to activate the light sources and enable the physician and otheroperating personnel to better view the operating site on the patient.Other manual switches, e.g. a foot activated switch, may be employed.Alternatively, the light sources may be automatically activated when theprobe component 11 is installed on the driver 12 or other events such aswhen electrical power is turned on. The driver component 12 may have abattery pack for the light sources 66 and 67.

The penetrating distal tip 16 may have a variety of tip shapes. Aparticularly suitable distal tip shape is described in provisionalapplication Ser. No. 60/532,277, filed on Dec. 23, 2003. Alternatively,the distal tip may be provided with an arcuate RF electrode such asdisclosed in U.S. Pat. Nos. 6,261,241, and 6,471,700, both assigned tothe present assignee.

The separate driver component 12 allows the entire probe unit to bedisposable. The drive gears of the drive component 12 control the motionof the tissue cutting member 20 for cutting and the motion of thetubular section 15 to orient the aperture 17. Other means (not shown)may provide mechanical and electrical power, vacuum, and control to theprobe device. Examples of replaceable snap-in type probe units aredisclosed in Burbank et al., U.S. patent application Ser. No.10/179,933, “Apparatus and Methods for Accessing a Body Site” herebyincorporated by reference in its entirety. Drive units such as thatdescribed in WO 02/069808 (which corresponds to co-pending U.S.application Ser. No. 09/707,022, filed Nov. 6, 2000 and U.S. applicationSer. No. 09/864,021, filed May 23, 2001), which are assigned to thepresent assignee, may be readily modified by those skilled in the art toaccommodate the movement of the cutting member 20.

The distal end of the probe component 11 is advanced within the patientwith the tissue cutter 20 in a forward or closed position (FIG. 4B),until the aperture 17 of the tubular section 15 is located in a desiredlocation for taking a tissue specimen. The tissue cutter 20 is thenwithdrawn proximally to an open position to open the aperture 17. Thewithdrawal of the tissue cutter can be used to control the length of theaperture which is opened in order to control the length of the specimenwhich is severed. A vacuum is applied to the interior 45 of the tissuecutter 20 to draw tissue at the site into the inner lumen of the tubularsection 15 through the aperture 17. The tissue cutter 20 is then drivendistally by rotation of probe gear 30 and rotated or oscillated by drivegear 40 engaging probe gear 41 to sever the aspirated tissue from thesupporting tissue at the target site with the tissue cutting surface 21.The vacuum within the interior of the tissue cutter 20 causes the tissuespecimen to be drawn through the inner lumen 45 of the tissue cutter 20and into the cartridge 58 of specimen collector 13 shown in FIG. 2.Positive pressure or even ambient conditions distal to the tissuespecimen can facilitate tissue passing through the interior 45 of tissuecutter 20. If another tissue specimen is desired, the tubular section 15may be rotated by the drive gear 22 engaging the probe gear 23 in one ormore steps to repeat obtaining another tissue specimen in the samemanner without otherwise moving the probe component 11. Typically, afirst tissue specimen is obtained with the aperture 17 of the probe 11in the 12 o-clock position, the second at the 3 o-clock position, thethird at the 9 o-clock position and the fourth at the 6 o-clockposition. The location of the second and third specimens may bereversed. The position of the aperture 17 may be indicated by a markerarrow 29 at the end cap 27 so that the physician or other operatingpersonnel can readily determine what the orientation of the aperture 17within the patient.

The biopsy system 10 may be hand held for some biopsy procedures or thesystem may be mounted on a stereotactic mounting stage 80 as shown inFIG. 9. A shoe 81 is slidably mounted to a rail 82 of a Fisher stage.The mounting member 83 is secured to the shoe 81 by a threaded post (notshown) secured to thumbwheel 84. As shown in FIG. 10, the bottom surface85 of the driver component 12 is configured to conform at least in partto the upper surface of the mounting member 83. The sampling and vacuumswitches 86 and 87 respectively on the driver component 12 are actuatedby the optional sampling and vacuum actuating elements 88 and 89 on themounting member 83. Alternatively, sampling and vacuum may be actuatedwith a foot pedal. As shown in FIG. 10, the driver component has anoperator dial 90 which when turned opens a threaded hole 91 forreceiving a threaded post (not shown) secured to the thumbwheel 84 andthe locating pin holes 92 and 93 which receive the complementary posts(not shown) in the mounting member 83.

As mentioned above, positive pressure or even ambient conditions willaid in passing the severed tissue specimen through the inner lumen 45 oftissue cutter 20 into the cartridge 58 of specimen collector 13. Asshown in FIGS. 4A and 4B venting valve can provide ambient pressurebehind the tissue specimen in the cutter interior 45 from the interiorof the tubular section 15. The valve body 50 is opened for atmosphericventing when the tissue cutter 20 is in the forward position upon thecompletion of severing the specimen from the tissue site. However, whenthe tissue cutter 20 is pulled back proximally the valve spring 49 urgesthe valve body 50 back to a closed position. While the tissue cutter 20is shown with a tissue cutting surface 21 which is perpendicular to thelongitudinal axis 28, the tissue cutting surface may be at an angle oreven parallel to the longitudinal axis as described in co-pendingapplication Ser. No. 10/642,406, filed Aug. 15, 2003.

The distal cutting edge 21 of the tissue cutter 20 may initially belocated proximal to the aperture 17 to provide a full aperture forreceiving tissue or it can be initially located within the aperture 17in order to control the length of the specimen. The cutting action oftissue cutter 20 preferably continues until the beveled cutting surface21 has completely traversed the aperture 17 to ensure that the tissuedrawn through the aperture is completely severed from supporting tissueat the biopsy site. A vacuum may be applied to aspirate the severedtissue specimen through the inner lumen of the tissue cutter 20 to thecartridge in the specimen collector at the proximal end of the biopsydevice. Positive pressure or access to ambient conditions may beprovided in the distal end of the tubular section to aid in the specimentransfer.

After the removable wall 57 of the specimen receiving cartridge 58 isremoved and the specimens therein removed, it is frequently desirable todeliver one or more markers to the target site from which the specimenshave been removed. Such marker delivery devices are shown in co-pendingapplication Ser. No. 10/753,694, filed on Jan. 7, 2004 and co-pendingapplication Ser. No. 10/444,770, filed May 23, 2003. However, the distalends of these marker delivery devices are very small and they can bedifficult to insert into the proximal end of the tissue cutter 20 whichis just slightly larger to accommodate the marker delivery shaft.

FIG. 11 illustrates a marker delivery device 100 which is particularlysuitable to facilitate the introduction of the distal end of the shaft101 into the inner lumen 45 of the tissue cutter 20 and the advancementtherein. As indicated into the inner lumen 45 of the tissue cutter 20 toeject one or more markers through the aperture 17 in the tubular section15 before the biopsy device 10 is removed from the patient. As shown inFIG. 13, to aid in the insertion of the small diameter distal tip 101 ofa marker delivery device 100 into the slightly larger inner lumen 45 ofthe tubular cutter 20 at its proximal end, the distal tip is preferablyprovided with an outwardly flared guide 102 which is slidably mounted onthe shaft 103 of the marker delivery device 100. The proximal end of thetubular cutter 20, the flared guide 102 and/or the distal tip 101 may beprovided with mating guide elements which orient the marker deliverydevice so that one or more markers are discharged through the aperture17 when the pusher element slidably disposed within the delivery deviceis urged distally to press at least one marker body out the dischargeopening in the distal portion of the elongated shaft of the markerdelivery device. The delivery of markers to the target site afterspecimen removal, while the distal end of the biopsy device is still atthe biopsy site, ensures that the markers are properly position at thebiopsy site. While the slidably mounted, flared proximal guide 102 isdescribed with respect to being disposed on the shaft 103 of markerdelivery device 101, the flared guide 102 has wide application within avariety of biopsy and other devices where one small diameter tubularmember is to be inserted into a slightly larger, but still smalldiameter second tubular member.

The elongated probe component 11 of the biopsy system 10 has a length ofabout 3 to about 20 cm, preferably, about 5 to about 13 cm, and morespecifically, about 8 to about 9 cm for breast biopsy use. To assist inproperly locating the probe 11 during advancement thereof into apatient's body, the distal extremity of the tubular section may beprovided with a marker at a desirable location that provide enhancedvisualization by eye, by ultrasound, by X-ray, MRI or other imaging orvisualization means. Manual palpation may also be employed. An echogenicpolymer coating that increases contrast resolution in ultrasound imagingdevices (such as ECHOCOAT™ by STS Biopolymers, of Henrietta, N.Y.) issuitable for ultrasonic visualization. Radiopaque markers may be madewith, for example, stainless steel, platinum, gold, iridium, tantalum,tungsten, silver, rhodium, nickel, bismuth, other radiopaque metals,alloys and oxides of these metals. In addition, the surfaces of thedevice in contact with tissue or other components of the device may beprovided with a suitable lubricious coating such as a hydrophilicmaterial or a fluoropolymer.

The tubular section and the tissue cutter are preferably formed of asurgical grade stainless steel. However, other high strength materialssuch as MP35N, other cobalt-chromium alloys, NiTi alloys, ceramics,glasses, and high strength polymeric materials or combinations thereofmay be suitable.

A patient's skin usually must be breached in order to gain access to abody site where a tissue specimen is to be obtained. A scalpel or othersurgical instrument may be used to make an initial incision in the skin.After the specimens have been taken, the biopsy device may be removedfrom the patient. The entire device may be removed; however, in someembodiments, the cartridge 58 may be removed from the system 10 and adelivery cannula may be inserted through the inner lumen of the cutter20 to deliver markers to the biopsy site through the aperture 17. Inaddition, it will be readily appreciated that other types of instrumentsmay be inserted into the tissue site through the tissue cutter inaddition to or in place of the instruments described above. Moreover,therapeutic or diagnostic agents may be delivered through the tissuecutter 20 or the tubular section 15.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. For example, while thevarious embodiments of the invention have been described herein in termsof a biopsy device, it should be apparent that the devices and methodsof utilizing the device may be employed to remove tissue for purposesother than for biopsy, i.e. for treatment or other diagnoses. Othermodifications include, for example, a tissue cutter slidably mountedaround the tubular section of the probe component rather than within thetubular section. Moreover, individual features of embodiments of theinvention may be shown in some drawings and not in others, but thoseskilled in the art will recognize that individual features of oneembodiment of the invention can be combined with any or all the featuresof another embodiment. Accordingly, it is not intended that theinvention be limited to the specific embodiments illustrated. It istherefore intended that this invention to be defined by the scope of theappended claims as broadly as the prior art will permit.

Terms such as “element”, “member”, “device”, “section”, “portion”,“means”, “step” and words of similar import, when used herein, shall notbe construed as invoking the provisions of 35 U.S.C. § 112(6) unless thefollowing claims expressly use the term “means” followed by a particularfunction without specific structure or the term “step” followed by aparticular function without specific action. All patents and patentapplications referred to above are hereby incorporated by reference intheir entirety.

What is claimed is:
 1. A method for collecting one or more tissuespecimens from a target site within a patient, comprising: a. providinga biopsy device having: i. a disposable elongated probe componentcomprising: an elongated tubular section which has a longitudinal axis,which has an inner lumen extending therein, which has a penetratingdistal tip and which has a tissue receiving aperture proximal to thepenetrating distal tip configured to receive tissue from the targetsite, a first driven gear coupled to the elongated tubular section andconfigured to rotate, to in turn rotate the elongated tubular sectionaround the longitudinal axis, an elongated tissue cutting member whichis disposed within the elongated tubular section, which has a distal endhaving at least one tissue cutting edge and which has an inner lumenextending therein, the elongated tissue cutting member having a proximalend opposite the distal end, and a second driven gear coupled to theelongated tissue cutting member and configured to rotate tolongitudinally move the elongated tissue cutting member relative to theelongated tubular section along the longitudinal axis, the first drivengear and the second driven gear being arranged coaxially and adjacenteach other on the longitudinal axis; ii. a driver component configuredto receive a proximal portion of the disposable elongated probecomponent in an operational relationship, the driver component having: afirst driver unit configured to rotate the elongated tubular section ofthe disposable elongated probe component to orient the tissue receivingaperture of the elongated tubular section, the first driver unit havinga first drive gear, and a second driver unit configured to drive theelongated tissue cutting member longitudinally within the elongatedtubular section to cut a tissue specimen from the tissue received in thetissue receiving aperture of the elongated tubular section, the seconddriver unit having a second drive gear positioned adjacent the firstdrive gear, the first drive gear and the second drive gear of the drivercomponent configured to respectively drivably engage the first drivengear and the second driven gear that are arranged coaxially and adjacentto each other on the longitudinal axis; and iii. a tissue collectiondevice located at the proximal end of the elongated tissue cuttingmember, a portion of the elongated tissue cutting member beingpositioned inside the tissue collection device; b. advancing thedisposable elongated probe component at least partially into or adjacentto tissue at the target site; c. rotating the elongated tubular sectionabout the longitudinal axis by the first driver unit to a predeterminedaperture orientation of the tissue receiving aperture; d. applying avacuum within the elongated tubular section to draw the tissue at thetissue site through the tissue receiving aperture of the elongatedtubular section into an interior thereof; e. advancing the elongatedtissue cutting member longitudinally within the elongated tubularsection by the second driver unit to cut the tissue specimen from thetissue extending into the elongated tubular section; and f. applying avacuum to the proximal end of the elongated tissue cutting member fortransporting the cut tissue specimen through the inner lumen of theelongated tissue cutting member to discharge the cut tissue specimendirectly from the proximal end of the elongated tissue cutting memberinto the tissue collection device.
 2. The method of claim 1, comprising:providing the disposable elongated probe component with a third drivengear coupled to the elongated tissue cutting member, the third drivengear being arranged on the longitudinal axis such that the third drivengear is coaxial with the first driven gear and the second driven gear onthe longitudinal axis; providing the driver component with a thirddriver unit having a third drive gear configured to drivably engage thethird driven gear, the third drive gear positioned adjacent the seconddrive gear; and driving the third driven gear with the third drive gearsimultaneously with driving the second driven gear with the second drivegear, such that the act of advancing the elongated tissue cutting memberlongitudinally is achieved by driving the second driven gear and the actof advancing the elongated tissue cutting member longitudinally isaccompanied by a rotational or oscillation motion of the elongatedtissue cutting member about the longitudinal axis by driving the thirddriven gear.
 3. The method of claim 1, comprising rotating the firstdriven gear in discrete rotational increments to in turn rotate theelongated tubular section about the longitudinal axis in discreterotational increments.
 4. The method of claim 3, wherein the discreterotational increments are increments of 30 degrees.
 5. The method ofclaim 3, wherein the discrete rotational increments are multiples of 30degrees.
 6. A method for collecting a tissue specimen from a target sitewithin a patient, comprising: a. providing a biopsy device having: i. adisposable elongated probe component comprising: an elongated tubularsection which has a longitudinal axis, which has an inner lumenextending therein, which has a penetrating distal tip and which has atissue receiving aperture proximal to the penetrating distal tipconfigured to receive tissue from the target site, a first driven gearcoupled to the elongated tubular section, an elongated tissue cuttingmember which is disposed within the elongated tubular section, which hasa distal end having at least one tissue cutting edge and which has aninner lumen extending therein, the elongated tissue cutting memberhaving a proximal end opposite the distal end, a second driven gearcoupled to the elongated tissue cutting member, and a third driven gearcoupled to the elongated tissue cutting member, wherein the first drivengear, the second driven gear, and the third driven gear are coaxial witheach other on the longitudinal axis; ii. a driver component which isconfigured to receive a proximal portion of the elongated probecomponent in an operational relationship, which has: a first driver unitconfigured to rotate the elongated tubular section of the elongatedprobe component to orient the tissue receiving aperture of the elongatedtubular section, the first driver unit having a first drive gearconfigured to drivably engage the first driven gear of the elongatedtubular section for rotating the elongated tubular section to positionthe tissue receiving aperture, a second driver unit configured to drivethe elongated tissue cutting member longitudinally within the elongatedtubular section to cut the tissue specimen from the tissue received inthe tissue receiving aperture of the elongated tubular section, thesecond driver unit having a second drive gear positioned adjacent thefirst drive gear, the second drive gear configured to drivably engagethe second driven gear for longitudinally moving the elongated tissuecutting member relative to the elongated tubular section, and a thirddriver unit configured to drive the elongated tissue cutting member inrotational or oscillation motion, the third driver unit having a thirddrive gear positioned adjacent the second drive gear, and configured todrivably engage the third driven gear for moving the elongated tissuecutting member in the rotational or oscillation motion; and iii. atissue collection device located at the proximal end of the elongatedtissue cutting member; b. advancing the elongated probe component atleast partially into the patient at the target site; c. rotating theelongated tubular section about the longitudinal axis to a predeterminedaperture orientation of the tissue receiving aperture by the firstdriver unit; d. applying a first vacuum within the elongated tubularsection to draw the tissue at the tissue site through the tissuereceiving aperture of the elongated tubular section into an interiorthereof; e. advancing the elongated tissue cutting member longitudinallywithin the elongated tubular section by the second driver unit, androtating or oscillating the elongated tissue cutting member within theelongated tubular section by the third driver unit, to cut the tissuespecimen from the tissue drawn into the elongated tubular section; andf. applying a second vacuum to the proximal end of the elongated tissuecutting member for transporting the tissue specimen through the innerlumen of the elongated tissue cutting member to discharge the cut tissuespecimen directly from the proximal end of the elongated tissue cuttingmember into the tissue collection device.
 7. A method of operating abiopsy device, comprising: a. providing a biopsy device having: i. adisposable elongated probe component including: an elongated tubularsection which has a longitudinal axis, which has an inner lumenextending therein, which has a penetrating distal tip and which has atissue receiving aperture proximal to the penetrating distal tipconfigured to receive tissue from a target site, and an elongated tissuecutting member which is disposed within the elongated tubular section,which has a distal end having at least one tissue cutting edge and whichhas an inner lumen extending therein, the elongated tissue cuttingmember having a proximal end opposite the distal end; ii. a drivercomponent which is configured to receive a proximal portion of theelongated probe component in an operational relationship, which has: afirst driver unit configured to rotate the elongated tubular section ofthe elongated probe component to orient the tissue receiving aperture ofthe elongated tubular section, a second driver unit configured to drivethe elongated tissue cutting member longitudinally within the elongatedtubular section to cut a tissue specimen from the tissue received in thetissue receiving aperture of the elongated tubular section, a thirddriver unit configured to drive the elongated tissue cutting member inrotational or oscillation motion; and iii. a first driven gear coupledto the elongated tubular section; iv. a second driven gear coupled tothe elongated tissue cutting member; v. a third driven gear coupled tothe elongated tissue cutting member, wherein the first driven gear, thesecond driven gear, and the third driven gear are coaxial with eachother on the longitudinal axis; vi. the first driver unit having a firstdrive gear configured to drivably engage the first driven gear of theelongated tubular section for rotating the elongated tubular section toposition the tissue receiving aperture; vii. the second driver unithaving a second drive gear positioned adjacent the first drive gear, thesecond drive gear configured to drivably engage the second driven gearfor longitudinally moving the elongated tissue cutting member relativeto the elongated tubular section; and viii. the third driver unit havinga third drive gear positioned adjacent the second drive gear, andconfigured to drivably engage the third driven gear for moving theelongated tissue cutting member in the rotational or oscillation motion;b. rotating the elongated tubular section about the longitudinal axis toa predetermined aperture orientation of the tissue receiving aperture bythe first driver unit; c. advancing the elongated tissue cutting memberlongitudinally within the elongated tubular section by the second driverunit; and d. rotating or oscillating the elongated tissue cutting memberwithin the elongated tubular section by the third driver unit.
 8. Themethod of claim 7, comprising driving the first driven gear in discreterotational increments to in turn rotate the elongated tubular sectionabout the longitudinal axis in discrete rotational increments.
 9. Themethod of claim 8, wherein the discrete rotational increments areincrements of 30 degrees.
 10. The method of claim 8, wherein thediscrete rotational increments are multiples of 30 degrees.
 11. Themethod of claim 7, wherein a driving of the third driven gear issimultaneous with a driving of the second driven gear.